The UK has introduced a new Innovative Licensing and Access Pathway (ILAP) aimed at reducing time to market for innovative medicines. This pathway involves collaboration between the developer, regulatory agency (MHRA), health technology assessment bodies (NICE, SMC), the payer (NHS England), and other partners from early stages of drug development.
Key takeaways
- Entry requires an "Innovation Passport" based on early non-clinical data showing potential significant benefits.
- A Target Development Profile (TDP) roadmap is created, covering regulatory, commercial, and access aspects.
- Options in the toolkit include accelerated assessment, real-world evidence, and rolling reviews.
- Patient input is incorporated, influencing development, approval, and access.
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